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Califf Asks NC's Life Science Crowd to Play Nice With FDA

Submitted by jshamp on Tue, 2017-02-28 10:30

Robert Califf, M.D., MACC

Globally renowned cardiologistRobert Califf, M.D., MACC, knew it was a temp job when he left his Duke University faculty position to ultimately become commissioner of the U.S. Food and Drug Administration.

He never sold his Durham home. And now he’s back home, with tickets to Duke basketball games in hand, and his Duke faculty gig welcoming him every day.

“It’s good to be back,” he told the hundreds of life science specialists gathered in Raleigh for the 2017 CED Life Science Conference. And he added that when people ask him if it was stressful at the FDA helm, he’s ready with the answer: “Leading the FDA is much less stressful than being on the faculty at Duke.”

No way to know if he’s joking.

Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke before being appointed FDA commissioner in the Obama Administration in February 2016. He is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, and has led many landmark clinical trials. He is one of the most frequently cited authors in biomedical science, with more than 1,200 publications.

Even though he’s no longer in charge of the FDA, Califf encouraged the crowd to play nice with the FDA he just left, with the turnover from the Obama to the Trump administration. The FDA is an agency Califf obviously admires for the professionals who staff it, and the depth and breadth of the jobs they’re called upon to perform.

“The FDA is a mysterious organization, poorly understood by most people,” he noted. But “the system works pretty well.”

As a physician and medical researcher, he said he didn’t understand the scope of FDA responsibilities for foods and cosmetics, let alone veterinary medicines. The FDA “doesn’t write the rule book, it interprets it.” And there’s an exponentially growing body of interpretation being required, thanks to layers of complexity in health maintenance and care, with new technologies such as personalized medicine, gene therapy, and combination products involving devices and biologics.

It’s a system that is “tested every day,” he said. “Every element is supported by law, regulation, guidance and precedent.”

“What I knew the least about was the food safety system,” he recalled from his FDA initiation. The complexity of the global food production and distribution system is enormous, said Califf. “It’s remarkable that you can come here and eat lunch and not worry about it.”

A product of Duke, a tobacco-based university, Califf left no doubt for anyone within earshot that he sees tobacco as the scourge that must be targeted by health officials before any of the more typical health threats like cancer and heart disease enter the picture.

“It was only in 2009 that the regulation of tobacco was established by Congress,” he noted. And he said the system still isn’t right, because it’s allowing electronic cigarettes to create new addicts among young people.

“In Europe there’s been a modest uptick in these nicotine delivery systems,” he said, “but it’s going through the roof in the U.S. Research needs to be done. It’s a critical issue for the FDA.

“Tobacco is the biggest modifiable disease factor we have, and the FDA has responsibility for regulating the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.”

It’s especially critical, he said, because nicotine and opioids are equally addictive. And both are major threats to the future of health in the U.S.

Califf noted that North Carolina is well positioned, as the global epicenter of contract research organizations, home to world-class research universities and a hotbed of information technology and data, to tackle the biggest health issues of today and tomorrow.

And all of that will ultimately cross paths with the FDA. Califf’s advice: “The FDA affects us all. Appreciate it and work with it."